The Effect of Cervical Physical Therapy Treatment in Patients With Somatic Tinnitus

NCT03131674 | Withdrawn

• 1 other identifier: 16/48/512
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigates the effect of cervical physical therapy on tinnitus annoyance in patients with somatic tinnitus. This study specifically enrolls patients with co-varying tinnitus and neck complaints, with low-pitched tinnitus or patients who's tinnitus can be influenced by neck movements or positions. These inclusion criteria were chosen, since a prior study showed that these factors were good prognostic indicators for a positive treatment effect.

Conditions

Tinnitus, Subjective

Keywords

Somatic tinnitus

Outcome Measures

Primary Outcomes (1)

• Tinnitus Questionnaire

  change in tinnitus distress after treatment and after follow-up

  Baseline, 9 weeks, 18 weeks

Secondary Outcomes (9)

• Tinnitus Functional Index

  Baseline, 9 weeks, 18 weeks

• Neck Bournemouth Questionnaire

  Baseline, 9 weeks, 18 weeks

• Change in Auditory evoked potentials

  Baseline, 9 weeks

• Change in Manual Rotation test

  Baseline, 9 weeks

• change in adapted Spurling test

  baseline, 9 weeks

Study Arms (2)

Direct treatment

EXPERIMENTAL

Other: Cervical physical therapy

Delayed treatment

EXPERIMENTAL

Other: Cervical physical therapy

Interventions

Cervical physical therapy OTHER

Patients receive a multimodal cervical physical therapy treatment

Delayed treatment; Direct treatment

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with subjective tinnitus (Tinnitus Functional Index between 25 and 90 point) in combination with self-reported neck complaints (Neck Bournemouth Questionnaire \> 13 points) are included in case one of the following is present:
• Tinnitus and neck complaints increase and decrease together
• Tinnitus is low-pitched and increases during inadequate neck postures

You may not qualify if:

• Tinnitus related to Ménière's disease, clear otological or neurological causes
• Serious depression
• Contra-indications for cervical spine treatment
• Patient already received cervical physical therapy in the past 2 months

Sponsors & Collaborators

• Universiteit Antwerpen: lead
• University Hospital, Antwerp: collaborator

Study Sites (1)

University Hospital of Antwerp

Edegem, Antwerp, 2650, Belgium

Location

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post-doctoral researcher

Model Details: We use a delayed treatment design, where both groups receive the same treatment. One group receives the treatment immediately after the inclusion. The other group receives the treatment after a 9-weeks delay.

Study Record Dates

• First Submitted: April 19, 2017
• First Posted: April 27, 2017
• Study Start: April 1, 2017
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: June 13, 2019

Record last verified: 2019-06

Locations

BE (1)